MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

Catalog Number	A-6000-08LF
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An appropriate device code could not be determined therefore device code 3191 was used.The device history record of the product a-6000-08lf batch number 74f1902185 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.An nc report was issued for the lot in question, but there are not related with the issue reported.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that an issue occurred with 2 separate patients; in both cases once installed the drain began to foam during activation.The junctions were checked, and everything seemed to be in order.Further information indicates that the foam was produced continuously in the area for blood collection.The foam was large enough to spread to neighboring compartments.Drains were installed for blood effusions.We used the solution that was provided with the pleur-evac unit.Foaming occurred when it was connected to the patient and on activation of the suction.We checked all the connections several times, but the foam continued to occur despite everything.We changed the units in both cases and the problem was resolved.There was no reported patient injury.

• Brand Name: PE ADULT-PED DRY/ WET LF 6/CS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9665845
• Report Number: 3004365956-2020-00040
• Device Sequence Number: 19618436
• Product Code: KDQ
• UDI-Device Identifier: 44026704428791
• UDI-Public: 44026704428791
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2022
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74F1902185
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1